Pharmaceutical Process Specialist

2 settimane fa


Bologna, Emilia-Romagna, Italia Commissioning Agents Inc A tempo pieno

Position Overview: We are seeking a **Pharmaceutical Process Specialist** with a robust understanding of Good Manufacturing Practices (GMP) within the pharmaceutical industry. This role is ideal for individuals with a background in Technology Transfer, Project Management, and the production of intricate pharmaceutical formulations.

Key Qualifications:
  • In-depth knowledge of the primary regulations governing Pharma GMPs
  • Proven experience in Technology Transfer as a Subject Matter Expert (SME) in Process Technology or Process Validation
  • Demonstrated project management skills, particularly in Technology Transfer initiatives
  • Experience in the manufacturing of aseptic drug products, lyophilized formulations, biological products, and biotechnology/biosimilar products
  • Expertise in Cleaning Validation processes
Additional Preferred Experience:
  • Creating Validation/Verification Master Plans
  • Conducting formal risk assessments and Failure Mode and Effects Analysis (FMEA)
  • Managing Change Control processes
  • Overseeing Corrective and Preventive Actions (CAPA)
  • Identifying Critical Quality Attributes and Critical Process Parameters
  • Experience in Commissioning and Qualification activities
  • Developing User Requirements documentation
  • Planning and executing project schedules
  • Establishing performance metrics and leading teams to meet objectives
  • Facilitating collaborative meetings


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